Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives

Cancer Colorectal Clinical Trial

— EDUCANCOLAGE  

Official title:

Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives - Randomized, Multicenter Cluster Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084133
• Other study ID #: INCA14-TL/EDUCANCOLAGE
• Secondary ID: 2015-A01514-45
• Status: Completed
• Phase: N/A
• Start date: April 10, 2017
• Est. completion date: January 19, 2019

Study information

• Verified date: September 2019
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The relative risk of colorectal cancer (CRC) is increased in first-degree relatives of patients with CRC or advanced adenoma. In the high-risk CCR population defined by a family history at the first stage of CRC or advanced adenoma before age 60, total colonoscopy is the recommended screening test. In France, the rate of screening colonoscopy in this population at high risk of CRC is insufficient, which limits the effectiveness of this targeted screening.

The main reason for this low participation rate is that most patients undergoing RCC or advanced adenoma are unaware of the family implications of their diagnosis and therefore reluctant to disseminate this information to their patients Related matters. The need for a better perception of the personal risk of CRC in first-degree relatives of patients with CRC or advanced adenoma, with the expected coronary adherence to increasing screening, requires a good understanding of risk through Clear, adapted and comprehensible information that can be relayed personally by the case-index.

The objective of this project is to develop a personalized prevention and screening program for the JRC in order to meet the needs of the relatives of the sick. The means of intervention that will be implemented respond to the need to better take into account the level of CRC risk in a family-based CRC screening and prevention approach adapted to a high-risk CRC group characterized by Family history at the first stage of CRC or advanced adenoma and, consequently, to improve the information of the subjects concerned by screening and prevention of CRC.

The aim of the case-index education is to induce its intervention with its relatives to promote CCR screening. The use of the index case, as a means of providing information to relatives, implies an educational and psychological approach, based on evidence, but adapted and personalized.

Description:

The relative risk of colorectal cancer (CRC) is increased in first-degree relatives of patients with CRC or advanced adenoma. In the high-risk CCR population defined by a family history at the first stage of CRC or advanced adenoma before age 60, total colonoscopy is the recommended screening test. In France, the rate of screening colonoscopy in this population at high risk of CRC is insufficient, which limits the effectiveness of this targeted screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 19, 2019
• Est. primary completion date: January 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

List of inclusion criteria

Index case:

• Patients with colorectal adenocarcinoma or advanced adenoma diagnosed (definition of advanced adenoma (Winawer, 2006): adenoma of diameter = 10 mm and / or severe dysplasia and / or with a villous contingent).

• Patients with at least one relative of the first degree belonging to the target population of the screening strategy evaluated (between 40 and 75 years of age and less than 10 years of age of the case-index) and residing in France.

• Affiliation of the patient to a social security scheme (including CMU).

• Understanding of the French language.

Related:

• They correspond to the target population at high risk of colorectal cancer targeted by this program of promotion of colonoscopy screening:

• Subjects related to 1st degree to the index case and in contact with it.

• Age between 40 and 75 years of age or less than 10 years of age of the index case.

• Resides in France

List of exclusion Criteria :

Index case :

• Chronic inflammatory bowel disease.

• Genetic predisposition syndrome identified with colorectal cancer (Lynch syndrome, familial polyposis linked to the APC and MYH genes).

• Patient's knowledge of a first-degree relative with colorectal adenocarcinoma or advanced adenoma.

• Isolated patient of his / her first-degree relatives and not wishing to re-establish contact with them.

• Advanced colorectal cancer with a life expectancy <6 months and / or a WHO = 2 general condition.

• Transmission of information to the family already carried out.

Related :

• Not applicable

Related Conditions & MeSH terms

• Adenoma
• Cancer Colorectal
• Colorectal Neoplasms

Intervention

Behavioral:
• Therapeutic Education Strategy
In the experimental arm of the study ("intervention group"), a screening information and education system will be implemented. The particularities of the index cases likely to require an adaptation of the device will be collected, analyzed and taken into account (level of health literacy, socio-economic status, level of education, professional activity ...). The analysis and intervention frameworks derived from theories on health behaviors will be mobilized (theory of reasoned action, theory of planned behaviors) and applied in order to reinforce the "intention" of the target audience. The analysis and intervention frameworks resulting from the educational sciences will be integrated with a "competence" approach (Aizen, 1991, Denovel, Dufour, Prochaska, 1983, Le Boterf, 2002).

Locations

Country	Name	City	State
France	Service d'Hépatogastro-entérologie CHU ANGERS	Angers
France	Service d'Hépatogastro-entérologie CHG BLOIS	Blois
France	Service d'Hépatogastro-entérologie CHG de DREUX	Dreux
France	Service de Médecine CHG de Loches	Loches
France	Service d'Hépatogastro-entérologie CHU de NANTES	Nantes
France	Service d'Hépatogastro-entérologie CHR d'Orléans	Orleans
France	Service d'Hépatogastro-entérologie CHU POITIERS	Poitiers
France	Service d'Hépatogastro-entérologie CHRU de TOURS	Tours

Sponsors (9)

Lead Sponsor	Collaborator
University Hospital, Tours	Clinic LE MANS, Hospital BLOIS, Hospital DREUX, Hospital LOCHES, Nantes University Hospital, Poitiers University Hospital, University Hospital, Angers, UNIVERSITY HOSPITAL, ORLEANS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.	Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.	12 MONTHS
Secondary	Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.	Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.	12 MONTHS
Secondary	Social and demographic factors in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.	Social and demographic factors in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.	12 MONTHS
Secondary	Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.	Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.	12 MONTHS
Secondary	How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.	How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.	12 MONTHS
Secondary	Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).	Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).	2 MONTHS
Secondary	Rate of colorectal cancer.	Rate of colorectal cancer.	12 MONTHS
Secondary	Rate of advanced adenomas.	Rate of advanced adenomas.	12 MONTHS
Secondary	Detection rate of scallop lesions.	Detection rate of scallop lesions.	12 MONTHS
Secondary	Rate of complications in screening colonoscopies.	Rate of complications in screening colonoscopies.	12 MONTHS
Secondary	Quality criteria for screening colonoscopy using the following parameters: visualization rate of the bottom of the colon, the withdrawal time of the colonoscope (Withdrawal time), quality of the colic preparation using the Boston scale.	Quality criteria for screening colonoscopy using the following parameters: visualization rate of the bottom of the colon, the withdrawal time of the colonoscope (Withdrawal time), quality of the colic preparation using the Boston scale.	12 MONTHS